Send a text message to the show!

For all its ease and speed, disproportionality analysis can be distorted by many biases, making it easy to misuse and misinterpret. Michele Fusaroli from Uppsala Monitoring Centre and Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb explain why we shouldn’t abuse this powerful but fragile tool.

Tune in to find out:

• Why we should never treat disproportionality signals as verdicts
• How poorly performed analyses affect scientists, regulators and patients
• How to avoid the most common sources of bias

Want to know more?

• Michele and Eugene’s paper in Drug Safety is a concrete guide to charting and sidestepping the pitfalls of disproportionality analysis.
• In another Drug Safety paper, Michele and colleagues show how directed acyclic graphs (DAGs) can help map and address biases in disproportionality analysis.
• Michele also reviewed the method’s limitations in Uppsala Reports, where he argues that ‘pharmacovigilance must move past crude disproportionality’.
• Last year, Retraction Watch covered the spike in pharmacovigilance studies in the literature and why some journals decided to ban drug safety database papers.
• Previously on Drug Safety Matters, Michele and Daniele Sartori discussed the READUS-PV guidelines for reporting disproportionality analyses.
• In 2016, the IMI PROTECT project published recommendations to improve signal detection practices, especially for quantitative methods like disproportionality analysis.
• UMC’s guidebook on signal detection in small datasets offers step-by-step advice for qualitative methods and manual case review.

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send a text message to the show!

Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk.

In this two-part episode, Omar Aimer, President of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.

Tune in to find out:

• How reporting for medical devices differs from medicines and vaccines
• How AI may be used for predictive safety monitoring
• Why regulatory and data harmonisation remains the key to improving medical device safety

Want to know more?

Listen to the first part of the interview here.

If you would like to learn more about the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.

Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.

Founded in 2018, ISoP’s Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send a text message to the show!

Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.

In this two-part episode, Omar Aimer, president of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.

Tune in to find out:

• What defines a medical device and how prevalent they are in our society
• Why device safety monitoring is different from medicines and vaccines, and where current surveillance still falls short
• How global initiatives aim to strengthen safety monitoring standards

Want to know more?

Listen to the second part of the interview here.

If you would like to learn more on the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.

Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.

Founded in 2018, ISoP’s Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send a text message to the show!

This special episode was recorded just before the 43rd Annual Meeting of the WHO Programme for International Drug Monitoring wrapped up in Cairo, Egypt. Held from 27 to 29 October 2025, the meeting brought together representatives from more than 80 member states, along with senior experts and regulatory leaders from WHO headquarters and regional offices. Discussions focused on strengthening pharmacovigilance for women of childbearing age and children, in light of WHO’s newly finalised Global Smart Pharmacovigilance Strategy.

In this episode, you’ll hear an abridged interview with Shanthi Pal, WHO Pharmacovigilance Team Lead, as she unpacks the new strategy and what it means for countries.

Want to know more?

• Read WHO’s “Global smart pharmacovigilance strategy” (Geneva: World Health Organization; 2025).
• Explore WHO’s work on pharmacovigilance through the Programme for International Drug Monitoring (PIDM) and the WHO Pharmacovigilance Team.
• Learn more about regulatory systems strengthening and the WHO Global Benchmarking Tool (GBT) for medicines and vaccines.
• Discover the WHO network for regulatory systems strengthening – the Coalition of Interested Parties (CIP), of which UMC is a member.
• Visit the UMC website to find out more about the WHO PIDM and UMC’s role in it.

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send a text message to the show!

Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities but also increased the stakes. How do we use them without losing trust and where do we set the limits?

In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.

Tune in to find out:

• How to keep up with rapid developments in AI technology
• Why model and performance transparency both matter
• How to protect sensitive patient data when using AI

Want to know more?

Listen to the first part of the interview here.

The CIOMS Working Group XIV published its recommendations for the use of AI in pharmacovigilance in December 2025.

Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare.

Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article.

Other recent UMC publications cited in the interview or relevant to the topic include:

• a pre-print on the revised vigiMatch algorithm for duplicate detection
• an article on the pitfalls of disproportionality analysis
• a pre-print on critically appraising AI applications for rare-event recognition

For more on the ‘black box’ issue and maintaining trust in AI, revisit this interview with GSK’s Michael Glaser from the Drug Safety Matters archive.

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send a text message to the show!

Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities, but they have also increased the stakes. How do we use them without losing trust and where do we set the limits?

In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.

Tune in to find out:

• Why pharmacovigilance needs specific AI guidelines
• How a risk-based approach to AI regulation works
• Where in the PV cycle is human oversight most needed

Want to know more?

Listen to the second part of the interview here.

The CIOMS Working Group XIV published its recommendations for the use of AI in pharmacovigilance in December 2025.

Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare.

Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article. His favourite definition of AI remains the one proposed by Jeffrey Aronson in Drug Safety.

For more on maintaining trust in AI, revisit this interview with GSK’s Michael Glaser from the Drug Safety Matters archive.

The AI methods developed by UMC and cited in the interview include:

• vigiMatch for duplicate detection
• vigiGroup for clustering
• vigiRank for signal detection
• vigiGrade for case report completeness scoring
• WHODrug Koda for automated coding

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send a text message to the show!

Children deserve the safest possible healthcare, yet they remain one of the most vulnerable patient populations when it comes to medicines safety. Ahead of World Patient Safety Day on 17 September, we discuss challenges and solutions in paediatric pharmacovigilance with ISoP president Angela Caro-Rojas.

Tune in to find out:

• Why we need a Patient Safety Day
• How to prevent common medication errors in children
• How to build child-friendly healthcare environments

Want to know more?

Visit the World Health Organization’s campaign website to learn more about World Patient Safety Day and download campaign materials.

You can also show support for the campaign by joining ISoP's free virtual event on September 18 and 19, or visit ISoP's YouTube channel to access recordings from previous Patient Safety Day events.

For more on paediatric pharmacovigilance and ISoP’s activities, check out these episodes from the Drug Safety Matters archive:

• The KIDs List
• What’s trending in pharmacovigilance?

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.